FX V135(TM) Shoulder Prosthesis

FX V135(TM) Shoulder Prosthesis is an FDA 510(k)-cleared medical device (K223801) manufactured by Fx Shoulder USA, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2023. Regulation: 8.